DEVICE: Streamline TL Spinal Fixation System (00191083024752)
Device Identifier (DI) Information
Streamline TL Spinal Fixation System
10-55-PR-80
Not in Commercial Distribution
10-55-PR-80
Rti Surgical, Inc.
10-55-PR-80
Not in Commercial Distribution
10-55-PR-80
Rti Surgical, Inc.
ROD, PRE-BENT
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 67309 | Spinal fixation implant/sterilization container set |
A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| NKB | Thoracolumbosacral pedicle screw system |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c8784b16-c641-4f0c-8141-f26201a6afa6
November 20, 2025
8
June 25, 2021
November 20, 2025
8
June 25, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(386)418-8888
labeling@rtix.com
labeling@rtix.com